Method of sterilization

ABSTRACT

A sterilized chemical composition is stored in a sterile environment for a prolonged period of time, hermetically sealed in successive enclosures and a shipping enclosure. The third sealing layer is removed prior to entering a storage area. The second layer is removed prior to taking the container to the sterile environment. The storage area may also be sterile. The innermost container may be an aerosol container and the composition a disinfectant liquid such as alcohol. The entire shipping enclosure and contects is preferably sterilized with gamma radiation.

This application is a continuation of application Ser. No. 09/627,398now U.S. Pat. No. 6,333,006 filed on Jul. 27, 2000, which is acontinuation of application Ser. No. 08/142,049 now U.S. Pat. No.6,123,900, filed Oct. 28, 1993.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention pertains to methods of optimizing the sterilizationprocess for chemical compositions and to allow extended shelf life forsterilized chemical compositions on-site for operational use. Inparticular, the subject invention concept is directed to a method ofsterilizing chemical compositions utilizing irradiation techniques whichallow for the chemical composition being sterilized to be maintainedwithin containers for extended periods of time with the assurance thatthe contents are maintained in a sterilized state. Still further, thisinvention concept is directed to an improved sterilization method forchemical compositions in general and particularly for isopropyl alcoholused in decontamination procedures. More particularly, this invention isdirected to a method where chemical compositions within containers arehermetically sealed to provide a relatively contaminant free outersurface subsequent to a gamma irradiation process for sterilization ofthe contents of the container being sealed. Still further, thisinvention directs itself to a method wherein a hermetically sealedcontainer is further hermetically sealed with a second sealing layerwhich in itself is formed around and encases the first sealing layer andcontainer. More in particular, this invention directs itself to a methodof optimizing the sterilization procedure for a chemical composition byproviding a third sealing layer around one or a plurality of doublesealed containers prior to a gamma ray irradiation process. Stillfurther, this invention provides for a series of processing stepswhereby a carton containing sterilized containers may be shipped to arelatively contaminated area and removed to a relatively contaminationfree area while still maintaining a double hermetic seal around thesterilized containers.

2. Prior Art

Sterilization procedures for chemical compositions are well known in theart. However, increasing statutory demands call for extended,complicated and time-consuming sterilization procedures which requiredetailed cataloguing and analysis associated with the assurance that asterilized composition is being maintained in a sterilized state over aperiod of time so that such can be assured of being sterilized whenoperationally used.

In some prior art techniques, a single covering layer is used forsealing irradiated chemical compositions. However, such sterilizedchemical compositions lose their sterilization ratings over an extendedperiod of time due to the fact that even when on the shelf of a cleanroom, such are impinged with various microorganisms and contaminationparticulates. Thus, shelf lives had to be catalogued with the resultthat there was extended periods of time used in documenting as well asanalyzing sterilization procedures in maintaining the sterilizationrequirements. Still further, in other prior art systems, the contents ofa container were irradiated however, no sealing layers were added whicheven further decreased the sterilization maintenance of the containedchemical compositions.

SUMMARY OF THE INVENTION

This invention is directed to a method of sterilization which includesthe step of providing a chemical composition to be sterilized. Thechemical composition is then charged into a container and the containeris encased within a first sealing layer forming a single layer sealedcontainer enclosure. The single layer sealed container enclosure is thenencased within a second sealing layer forming a second layer sealedcontainer enclosure. Both the first and second sealing layers providefor hermetic sealing and the entire second layer sealed containerenclosure is inserted into a carton which is lined with a third sealinglayer. The third sealing layer is then closed and the entire carton isirradiated at a predetermined radiation level for sterilizing thechemical composition contained within the original container.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a block diagram showing the method steps for the method ofsterilization as herein described;

FIG. 2 is a cross-sectional view of a first sealing layer being placedover a chemical container;

FIG. 3 is a cross-sectional view of a second sealing layer encasing thefirst sealing layer and forming a second layer sealed containerenclosure;

FIG. 4 is a cross-sectional view of a carton having a third sealinglayer lining for insertion of the second layer sealed containerenclosure; and,

FIG. 5 is a perspective view of a closed carton member being irradiatedin a plurality of planes.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now to FIGS. 1-5, there is shown a method of sterilization formaintaining chemical compositions in a sterilized state over an extendedperiod of time. The subject invention concept is directed to both thecombined sterilization process for chemical compositions in combinationwith the maintenance of the sterilization state for the chemicalcompositions over a long period of time in order that the user maysafely use the sterilized compositions at their discretion with theassurance that the chemical composition remains in a sterilized state.Thus, the problems associated with sterilization are two-fold in naturewhere the initial problem of sterilization is only one portion of themaintenance of the sterilization concept of the subject method. Ingeneral, chemical compositions are sterilized and then shipped incartons such as cardboard containers with a plastic lining to protectthe sterilized compositions maintained in their own containers withinthe cardboard cartons. The cardboard cartons are generally shipped bynormal shipping procedures such as trucks, rail cars, or airtransportation. The cartons are brought to the site where the sterilizedcontainers are to be used and in general, procedures have been workedout where the containers and their plastic enclosure are broughtinternal to the work place while the container which may by then havevarious contaminating microbes or other particulates are left externalto the workplace. The workplace then may store the chemical compositioncontainers in a clean room or other type of room which in itself isdesignated as a room relatively free of contaminants but such cleanrooms also have microbes and various other contaminating particulates inthe atmosphere. Thus, a shelf life must be designated for suchsterilized chemical composition containers even when used in a cleanroom type of atmosphere.

In order to solve the problem of shelf life, the subject inventionconcept's method provides for a series of steps which allow thesterilized chemical compositions within their own containers to bemaintained over extended periods of time without a shelf life dependenton the sterilized state being designated nor being important to themaintenance of the chemical composition sterilization.

The use of the subject invention concept method for sterilization ofchemical compositions has great use in the pharmaceutical industry. Thepharmaceutical industry uses a large amount of alcohol fordecontamination since it does kill various organisms. Thus, thepharmaceutical industry demands sterile alcohol and in particular thechemical compositions as herein described and detailed direct themselvesto alcohol compositions and particularly to isopropyl alcohol usedextensively in the pharmaceutical industry.

Referring now to FIG. 1 which provides a block diagram associated withthe overall method of sterilization as herein described, the chemicalcomposition is obtained from a vender and assayed in block 10 wherein itis determined that a proper formulation of the chemical composition hasbeen received. In the case of isopropyl alcohol many different types ofcomposition formulations may be required under varying statutory lawsassociated with sterilization in different environments. In general, ifan alcohol such as isopropyl alcohol is used it may be assayed ormeasured to provide predetermined compositions or formulations, two ofthe standards being 70% isopropyl alcohol with 30% water or 91%isopropyl alcohol and 9% water by volume.

The analyzed and measured chemical composition is then passed to afilter mechanism represented by block 20 in FIG. 1. The filter shown inblock 12 may be a standard mechanical filter such as a cartridge filterhaving a predetermined filtering range such as a 0.22 micron filter toallow removal of particulate matter greater than the filter size. Ineffect, filter 12 removes residual particulates that may be in thechemical composition and at the size range of 0.22 microns even removesbacteria that may be in the chemical composition liquid. Thus, certainbacteria and spores as well as other particulate contaminants areremoved during this phase of the overall method of sterilization.

The chemical composition is brought from the mechanical filter 12 toblock 14 which is a test for particulate or microscopic matter. Testingis done in accordance with Test Number 788 dictated in the USP XXIIJournal for determination of particulate matter contained within variouschemical compositions. The test procedure is well known and used as astandard in the chemical industry where the composition is mixed in acontainer and the chemical composition has a vacuum applied thereto toallow passage into and through a filter. A section of the filterassembly is removed from the container while maintaining the vacuum andthe filter is then placed in a Petri slide. The filter is dried with thecover of the Petri slide slightly open and particles on the filter arecounted. Such testing is well known in the art and determines whetherparticulate matter of predetermined sizes has been removed from thechemical composition.

Once the particulate material testing in block 14 has been completed,the chemical composition is then brought to a secondary concentrationtest block 16 where the concentration of the chemical composition isonce again analyzed to make sure that the proper chemical compositionformulation has teen maintained. Secondary concentration test block 16may be a standard well known concentration test as was provided in block10. Once the chemical composition has passed through secondaryconcentration test block system 16, the chemical composition is thenready for packaging and has been assured of a proper formulationcomposition as well as an assurance to the fact that predeterminedparticulate sizes have been removed from the overall chemicalcomposition.

Thus, in the flow blocks associated with FIG. 1, after passage throughthe initial concentration or assaying test block 10, mechanical filter12, testing for microscopic material 14 and insertion into the secondaryconcentration test block 16, there has been provided a chemicalcomposition of predetermined concentration which is to be sterilized inaccordance with the invention concept steps of the subject method.

After the secondary concentration testing as shown in block 16 iscompleted, container 20 shown in FIGS. 2 and 3 is filled with thechemical composition as provided in block 18 of FIG. 1. Chemicalcomposition container 20 may be a standard aerosol can or alternativelymay be a container with a cap closure. When using isopropyl alcohol asthe chemical composition, such is generally inserted under pressure withan inert element such as nitrogen or another chemical formulation actingas the propellant into an aerosol can type chemical compositioncontainer 20. Once the chemical composition is inserted into chemicalcomposition container 20 as shown in block 18, a nozzle may be mountedat one end with differing nozzle pattern generating systems being useddependent upon what is necessary for a particular decontaminationoperation. Such type of closure whether it be a nozzle arrangementsystem or a cap closure is not important to the inventive concept asherein described with the exception that such provide egress of thechemical composition appropriate for a particular decontaminationoperation. Once the filling composition container 20 has been filled,the operational phase moves to block diagram 22 of FIG. 1 wherecontainer 20 is encased within first sealing layer 24 forming a singlelayer sealed container enclosure 26.

First layer 24 seen in FIGS. 2 and 3, may be formed of a plasticcomposition of the closed cell type and in particular may be formed of apolyethylene composition. Once chemical composition container 20 hasbeen encased by first layer 24, first layer 24 may be heat sealed toform a substantially hermetic seal for chemical composition container 20as shown in FIG. 2. At this stage of the process steps, single layersealed enclosure 26 has been created and is moved to block 28 of FIG. 1where second sealing layer 30 encases single layer sealed enclosure 26to form second layer sealed container enclosure 32. Second sealing layer30 may also be formed of a plastic composition of the closed cell typeand in particular may also be a polyethylene composition similar tofirst layer 24. Second sealing layer 30 may then be also heat sealed toprovide a hermetically sealed second layer sealed container enclosure 32as shown in FIG. 3.

Once second sealing layer 30 has been applied and heat sealed toestablish second layer sealed container enclosure 32., the enclosure 32is then inserted into plastic lined carton 36 as shown in FIG. 4 anddepicted in flow block 34 of FIG. 1. Carton 36 may be a cardboard typecontainer adaptable for transportation and associated shipping to theoperations site. Additionally, there is provided third sealing layer 38as shown in FIG. 4, which is a lining for carton 36. Third sealing layer38 may once again be formed of a plastic type composition of the closedcell type which may also be a polyethylene bag-like element. Thirdsealing layer 38 lines the internal walls of carton 36 in order toprovide an insert for one or a plurality of second layer sealedcontainer enclosures 32 therein. Third sealing layer 38 may then beclosed through tying or some like closure mechanism at an upper section40 and in this manner the entire second layer sealed container enclosure32 is then contained therein. Finally, carton 36 may be closed in thestandard manner of flap closures for container members.

Once the second layer sealed container enclosure has been inserted intolined carton 36 as shown in block 34 of FIG. 1, carton 36 is thenbrought to block 42 for carton irradiation processes. The cartonirradiation step as depicted in block 42 of FIG. 1 may be a gammairradiation system where the decay of each atom of cobalt 60 generates apair of photons of gamma radiation having predetermined energies as wellas a beta particle. The beta particle is captured within a housing ofthe cobalt 60 and the photons of gamma radiation provide for thesterilization radiation process. In general, cartons 36 are brought intothe irradiation plant where the cobalt 60 is transported in shieldedflasks. Following transfer from the flasks to the irradiation plant,doubly encapsulated cobalt 60 in stainless steel tubes are incorporatedinto a three-dimensional array which form the energy source forprocessing carton 36 as depicted in FIG. 5 where the directional arrows44 show impingement of the gamma radiation in a three-dimensional arraydirection concept. Cartons 36 are generally passed through theirradiation plant on conveyor systems either using roller beds orsuspended carrier systems where the gamma radiation dose absorbed by thechemical composition within the closed cartons 36 is directlyproportional to the activity level of the source and the duration ofexposure.

Gamma radiation is generally used for sterilization of chemicalcompositions in that the gamma radiation has a high penetrationcapability. This high penetration capability enables relatively denseproducts or compositions to be processed easily. Dosages are generallydefined in Grays with one Gray representing the absorption of one Jouleof energy per kilogram of material. Sterilizing doses generally are inthe 25-35 kilogray range and as the products undergo the irradiationprocess, obviously the face of carton 36 facing the source of radiationwill receive a higher dosage than the side away from the source.

To insure appropriate dose levels between 20-40 kilograys, carton 36 ismeasured with dosimeters which measure the amount of irradiationimpinging on the closed carton 36. In this manner, the contents ofcontainer 20 is assured of appropriate irradiation levels being appliedthereto.

The closed cartons 36 are then prepared for shipping as provided inblock 44 of FIG. 1 and are transported for operational use downstream.

In this manner, when received at the operational site, closed cartons 36may be then opened and third sealing layer 38 contained therein may beremoved on the loading dock prior to entry into a clean room. Thechemical containers 20 are maintained within third sealing layer 38 in aclosed manner until removed and then brought to a clean room typeoperating site with the opened container 36 being left on the loadingdock.

Once transported into the clean room or other operational site, thirdsealing layer 38 may be removed and the chemical containers 20 formingsecond layer sealed container enclosures 32 may be placed on a shelf forfuture use. It must be remembered that at this point, there is both afirst layer 24 and a second sealing layer 30 encompassing chemicalcontainer 20. When placing the second layer sealed container enclosures32 on the shelves for use in the clean rooms, generally sterilizedgloves are used however, these in themselves as well as the atmosphereof clean rooms have various particulates such as microbes or bacteriawhich dictate a shelf life for chemical containers 20 if only a singlefirst layer 24 were formed around the chemical containers 20. However,with the first and second layers 24 and 30, the now somewhat less thansterilized second layer sealed container enclosure 32 may be kept on theshelf for an indefinite period of time prior to use of the contents ofchemical container 20.

Once the contents of chemical container 20 are to be used, secondsealing layer 30 may be stripped from second layer sealed containerenclosure 32 leaving first layer 24 surrounding and encasing chemicalcontainer 20 in a sterilized manner. Use then can be made of thecontents of chemical containers 20 with the assurance that such has beenmaintained in a sterilized state.

Thus, there has been shown a method of sterilization for chemicalcompositions in general and in particular isopropyl alcohol compositionswhere the chemical composition to be sterilized is provided prior toblock 10. In overall concept the chemical composition is secondarilytested for its appropriate concentration in block 16 with an additionaltest for particulate or microscopic material being made in block 14. Acontainer 20 is then charged with the chemical composition as providedin block 18 and container 20 is encased within first sealing layer 24forming a single layer sealed container enclosure 26 as provided inblock 22.

After the first sealing layer 24 is applied, the single layer sealedcontainer enclosure 26 is then encased within second sealing layer 30forming a second layer sealed container enclosure 32 as provided in flowblock 28. The encasement is provided for hermetically sealing initiallythe chemical container 20 with the first layer 24 and then the singlelayer sealed enclosure 26 with the second sealing layer 30 as shown inFIGS. 2 and 3.

The second layer sealed container enclosure 32 is then inserted into anopen carton member 36 which is lined with a third sealing layer 38 asshown in flow block 34 and depicted in FIG. 4. The carton member is thenclosed as depicted in FIG. 5 and irradiated at a predetermined radiationlevel for some predetermined time interval for sterilizing the chemicalcomposition contained within container 20.

Although this invention has been described in connection with specificforms and embodiments thereof, it will be appreciated that variousmodifications other than those discussed above may be resorted towithout departing from the spirit or scope of the invention. Forexample, equivalent elements may be substituted for those specificallyshown and described, certain features may be used independently of otherfeatures, and in certain cases, particular locations of elements may bereversed or interposed, all without departing from the spirit or scopeof the invention as defined in the appended claims.

I claim:
 1. A method of sterilizing a chemical composition contained ina sealed container comprising the steps of, under non-sterileconditions: providing a container having an internal volume; chargingthe internal volume of the container with a quantity of chemicalcomposition; sealing the internal volume of the container to form asealed container; hermetically heat sealing the container in a firstsealing layer to form a first hermetically heat-sealed containerenclosure; hermetically heat sealing said first hermetically sealedcontainer enclosure in a second sealing layer to form a secondhermetically heat-sealed container enclosure; enclosing said secondhermetically heat-sealed container enclosure in a shipping carton toform a closed shipping package the contents of which include saidchemical composition, said sealed container, and said first and secondhermetically heat-sealed container enclosures; transferring said closedshipping package with its contents in a non-sterile condition to anirradiation plant; and externally irradiating said closed shippingpackage and its contents at the irradiation plant at a predeterminedradiation level for a predetermined time interval to simultaneouslysterilize said chemical composition, said sealed container, and saidfirst and second hermetically heat-sealed container enclosures.
 2. Themethod of claim 1 comprising enclosing a plurality of said secondhermetically heat-sealed container enclosures in each of a plurality ofsaid shipping cartons to form a plurality of closed shipping packages,transferring said plurality of closed shipping packages and theircontents in a non-sterile condition to an irradiation plant, andexternally irradiating said closed shipping packages and their contentsat the irradiation plant at a predetermined radiation level for apredetermined time interval to simultaneously sterilize the chemicalcompositions, the sealed containers, and the first and secondhermetically heat-sealed container enclosures contained in each closedshipping package.
 3. The method of claim 2 wherein each container is anaerosol container and including the step of pressurizing the internalvolume of each aerosol container with an inert gas prior to sealing eachcontainer.
 4. The method of claim 1 wherein said first and secondsealing layers each consist of a single layer of a polyethylene plasticmaterial.
 5. A method of storing a sterilized chemical composition andmaintaining the sterilization shelf life of the sterilized chemicalcomposition for a prolonged period of time, said sterilized chemicalcomposition being contained in a plurality of sealed containers, eachsealed container being hermetically sealed in a first hermeticallysealed container enclosure, each first hermetically sealed containerenclosure containing a sealed container being hermetically sealed in asecond hermetically sealed container enclosure, a plurality of thesecond hermetically sealed container enclosures each containing a firsthermetically sealed container enclosure and a sealed container beingenclosed in a shipping enclosure to form a closed shipping package thecontents of which have been sterilized by radiation at an irradiationplant and transported to a storage area for operational use, comprisingthe steps of: opening the closed shipping package and removing thesterilized second hermetically sealed container enclosures eachcontaining a sterilized sealed container and a sterilized firsthermetically sealed container enclosure from the closed shippingpackage; storing the sterilized second hermetically sealed containerenclosures each containing a sterilized sealed container and asterilized first hermetically sealed container enclosure in the storagearea for a period of time; after the period of time, removing at leastone of the sterilized second hermetically sealed container enclosuresfrom the storage area, opening the removed second hermetically sealedcontainer enclosure and transporting the sterilized first hermeticallysealed container enclosure containing the sterilized sealed container toa sterile environment; and opening the sterilized first hermeticallysealed container enclosure in the sterile environment and removing thesterilized sealed container from the sterilized first hermeticallysealed container enclosure for use of the sterilized chemicalcomposition in the sterile environment.
 6. A closed shipping packageadapted to be terminally sterilized with radiation comprising aplurality of non-sterile, sealed aerosol containers each having aninternal volume and being charged with a quantity of a chemicalcomposition and pressurized with an inert gas, a non-sterile firsthermetically sealed container enclosure hermetically sealing eachaerosol container, a non-sterile second hermetically sealed containerenclosure hermetically sealing each first hermetically sealed containerenclosure, each non-sterile second hermetically sealed containerenclosure containing a non-sterile, sealed aerosol container containedwithin a non-sterile first hermetically sealed container enclosure, anda shipping carton enclosing a plurality of the non-sterile secondhermetically sealed container enclosures to form a non-sterile closedshipping package, the non-sterile closed shipping package externallyradiated at a predetermined radiation level for a predetermined timeinterval to simultaneously sterilize the chemical compositions, thenon-sterile, sealed aerosol containers and the non-sterile first andsecond hermetically sealed container enclosures.
 7. The closed shippingpackage of claim 6 wherein said chemical composition is alcohol and saidfirst and second hermetically sealed container enclosures consist of asingle layer of a polyethylene plastic material.